Overview

Clopidogrel for Acute Ischaemia of Recent Onset

Status:
Completed
Trial end date:
2019-02-01
Target enrollment:
0
Participant gender:
All
Summary
Evaluate the role of loading Clopidogrel in acute ischemic stroke in improving neurological outcome of stroke in cases patients will be non-eligible for, or declined, treatment with or intravenous thrombolysis with rTPA, rTPA is not available or thrombectomy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ain Shams University
Treatments:
Aspirin
Clopidogrel
Ticlopidine
Criteria
Inclusion Criteria:

1. First ever presentation with acute ischemic stroke. Previous transient ischemic
attacks (TIA's) are not excluding, regardless of their frequency or severity

2. Ictus to drug time does not to exceed 9 hours (allowing for at least 30 minutes to
obtain imaging)

3. Patients with undetermined time of onset will be included only if they were last seen
well within the same time window (9hrs). Onset of events in patients presented with
stuttering stroke will be considered from the onset of the first clinical
manifestation.

4. According to National Institute of Health Stroke Scale (NIHSS) on admission, patient
will be recruited with NIHSS between 4 and 24 (both inclusive).

Exclusion Criteria:

1. Patients eligible for intravenous (recombinant tissue plasminogen activator) rTPA
thrombolysis or thrombectomy.

2. If NIHSS on admission is 3 or less, 25 or more, or patients who are showing rapidly
resolving symptoms prior to the results of imaging.

3. Clinical seizures at the onset of stroke.

4. Patients with known history or manifestations of any major organ failure.

5. Patients who have had acute myocardial infarction within 1 month; and/or with
management interfering with the current study (e.g. warfarin).

6. Patients with active malignancies, and/or have been on chemo- or radiotherapy within
the last year.

7. Patients with active peptic ulcer and/or (gastrointestinal tract) GIT surgery or
bleeding within the last year.

8. Persistent uncontrolled vomiting during the first day of admission.

9. Patients with major surgery within the last 3 months.

10. Patients with history of uncontrolled bleeding site, within the prior year.

11. Patients with known allergy to study drugs.

12. Patients with known history of persistent or recurrent (central nervous system) CNS
pathology (e.g. epilepsies, meningioma, multiple sclerosis).

13. Patients with past history of head trauma with residual neurological deficit

14. Patients who are on regular Clopidogrel during the week before admission.

15. Patient with raised prothrombin time (PT) on admission, either on anticoagulants (with
raised INR>1.3, PT >18 second) or not (PT> 15 second), or on drugs that might increase
possibility of peripheral bleeding (e.g. corticosteroids).

16. Patients who have an indication for full anti-coagulation during the first week of
their hospital stay will be retrospectively excluded.

17. Patients receiving anti-coagulants in deep venous thrombosis (DVT) prophylaxis doses
will NOT be excluded:

- Enoxaparin 40mg/d (or equivalent).

- Heparin with partial thromboplastin time (PTT) not exceeding 50 seconds.

- Oral anticoagulation with INR <1.5.

18. Pregnancy or breast feeding

19. Stroke due to venous thrombosis

20. Hemorrhagic stroke

21. Blood pressure < 90/60 or > 185/110 mmHg, if not responding to intravenous
antihypertensive therapy or requiring aggressive treatment to reduce it below this
limit

22. Arterial puncture in a non-compressible site within the previous week

23. Strokes following cardiac arrest or profuse hypotension.

24. Blood glucose level < 50 or > 400 mg/dl on admission

25. CBC with picture of severe anemia (Haematocrit <0.25), thrombocytopenia (Platelets <
100,000) or leucopenia (WBC < 3,000).

26. Significant electrolyte imbalance that may account for the presenting manifestations

27. Contraindications to imaging

28. Urgent brain CT revealing any of the following:

- Hemorrhage.

- Major cerebral non-vascular pathology.

- Suspected arterio-venous malformation (AVM).

- Previous intracerebral hemorrhage or old infarctions larger than 1.5 cm.

- Massive acute hypo density in the brain region corresponding to the current
symptoms.